Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder (NCT00735709) | Clinical Trial Compass
CompletedPhase 3
Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Australia, Czechia560 participantsStarted 2008-08
Plain-language summary
The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Has a primary diagnosis of major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
* The reported duration of the current major depressive episode is at least 3 months.
* Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥26.
* A male or a female of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication.
Exclusion Criteria:
* Has 1 or more the following:
* Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
* Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
* Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. (must have negative urine drug screen prior to Baseline).
* Presence or history of a clinically significant neurological disorder (including epilepsy).
* Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
* Has a significant risk of suicide according to the investigator's opinion or has a score ≥…
What they're measuring
1
Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8